• 목록
• 답변
• 글쓰기
• 게시판 리스트 옵션
  • 수정
  • 삭제

Pragmatic Free Trial Meta

Pragmatic Free Trial Meta is a free and non-commercial open data platform and infrastructure that supports research on pragmatic trials. It collects and shares cleaned trial data and ratings using PRECIS-2, allowing for multiple and diverse meta-epidemiological studies that compare treatment effects estimates across trials that have different levels of pragmatism as well as other design features.

Background

Pragmatic trials are becoming more widely recognized as providing real-world evidence for clinical decision making. The term "pragmatic", however, is a word that is often used in contradiction and its definition and assessment need further clarification. Pragmatic trials should be designed to inform policy and clinical practice decisions, rather than to prove an hypothesis that is based on a clinical or physiological basis. A pragmatic study should try to be as similar to real-world clinical practice as is possible, including its selection of participants, setting and design as well as the implementation of the intervention, and the determination and analysis of outcomes as well as primary analysis. This is a significant difference from explanatory trials (as described by Schwartz and Lellouch1) which are designed to provide more complete confirmation of the hypothesis.

Trials that are truly practical should avoid attempting to blind participants or 프라그마틱 슬롯 무료체험 환수율 (https://dftsocial.com) clinicians as this could cause distortions in estimates of the effect of treatment. The pragmatic trials also include patients from various health care settings to ensure that their results can be generalized to the real world.

Additionally, clinical trials should concentrate on outcomes that are important to patients, like the quality of life and 프라그마틱 슬롯 무료체험 functional recovery. This is particularly relevant for trials involving surgical procedures that are invasive or have potentially serious adverse events. The CRASH trial29, for example was focused on functional outcomes to evaluate a two-page case report with an electronic system for monitoring of patients admitted to hospitals with chronic heart failure. Similarly, the catheter trial28 focused on urinary tract infections that are symptomatic of catheters as its primary outcome.

In addition to these characteristics pragmatic trials should reduce the procedures for conducting trials and data collection requirements to reduce costs. In the end the aim of pragmatic trials is to make their results as applicable to current clinical practice as is possible. This can be accomplished by ensuring their primary analysis is based on the intention-to treat approach (as defined in CONSORT extensions).

Many RCTs that don't meet the requirements for pragmatism but contain features contrary to pragmatism, have been published in journals of varying kinds and incorrectly labeled pragmatic. This could lead to false claims about pragmatism, and the term's use should be made more uniform. The creation of the PRECIS-2 tool, which provides an objective and standard assessment of practical features, is a good first step.

Methods

In a practical study, the goal is to inform clinical or policy decisions by demonstrating how an intervention could be integrated into routine treatment in real-world contexts. Explanatory trials test hypotheses concerning the cause-effect relationship within idealised conditions. In this way, pragmatic trials can have less internal validity than explanatory studies and be more susceptible to biases in their design as well as analysis and conduct. Despite these limitations, pragmatic trials may provide valuable information to decision-making in healthcare.

The PRECIS-2 tool scores an RCT on 9 domains, with scores ranging from 1 to 5 (very pragmatic). In this study the areas of recruitment, organisation, flexibility in delivery, flexible adherence, and follow-up were awarded high scores. However, the primary outcome and the method of missing data were scored below the practical limit. This suggests that it is possible to design a trial using excellent pragmatic features without damaging the quality of its results.

It is difficult to determine the degree of pragmatism within a specific trial because pragmatism does not possess a specific attribute. Some aspects of a study may be more pragmatic than other. Additionally, logistical or protocol modifications during the course of the trial may alter its score in pragmatism. Koppenaal and colleagues discovered that 36% of the 89 pragmatic studies were placebo-controlled, or conducted prior to the licensing. They also found that the majority were single-center. Thus, they are not as common and are only pragmatic in the event that their sponsors are supportive of the lack of blinding in these trials.

A common feature of pragmatic research is that researchers attempt to make their findings more meaningful by studying subgroups within the trial sample. This can result in unbalanced analyses with less statistical power. This increases the chance of omitting or ignoring differences in the primary outcomes. In the case of the pragmatic trials included in this meta-analysis, this was a major issue since the secondary outcomes weren't adjusted for variations in the baseline covariates.

Additionally, studies that are pragmatic can present challenges in the collection and interpretation safety data. This is due to the fact that adverse events are typically reported by participants themselves and are prone to delays in reporting, inaccuracies or coding deviations. It is important to improve the quality and accuracy of the outcomes in these trials.

Results

While the definition of pragmatism may not require that all clinical trials be 100% pragmatic, there are benefits to including pragmatic components in trials. These include:

Enhancing sensitivity to issues in the real world, reducing the size of studies and their costs as well as allowing trial results to be more quickly translated into actual clinical practice (by including patients who are routinely treated). However, pragmatic trials may have their disadvantages. For example, the right kind of heterogeneity can allow the trial to apply its results to different patients and settings; however, the wrong type of heterogeneity may reduce the assay's sensitiveness and consequently lessen the ability of a trial to detect minor treatment effects.

A variety of studies have attempted to categorize pragmatic trials using various definitions and scoring methods. Schwartz and Lellouch1 developed a framework to distinguish between explanatory studies that confirm a physiological or clinical hypothesis and pragmatic studies that guide the selection of appropriate therapies in real world clinical practice. Their framework comprised nine domains, each scored on a scale of 1 to 5, with 1 indicating more lucid and 5 suggesting more pragmatic. The domains were recruitment and setting, delivery of intervention with flexibility, 프라그마틱 무료 follow-up and primary analysis.

The initial PRECIS tool3 included similar domains and scales from 1 to 5. Koppenaal and colleagues10 developed an adaptation of this assessment, dubbed the Pragmascope that was easier to use in systematic reviews. They discovered that pragmatic reviews scored higher across all domains, however they scored lower in the primary analysis domain.

The difference in the primary analysis domain could be explained by the fact that the majority of pragmatic trials analyze their data in an intention to treat method however some explanation trials do not. The overall score for pragmatic systematic reviews was lower when the areas of management, flexible delivery and follow-up were merged.

It is important to understand that a pragmatic trial does not necessarily mean a poor quality trial, and indeed there is an increasing number of clinical trials (as defined by MEDLINE search, however this is not specific nor sensitive) which use the word 'pragmatic' in their abstracts or titles. The use of these words in abstracts and titles may suggest a greater awareness of the importance of pragmatism however, it is not clear if this is evident in the content of the articles.

Conclusions

In recent times, pragmatic trials are becoming more popular in research as the importance of real-world evidence is increasingly recognized. They are randomized trials that evaluate real-world alternatives to clinical trials in development. They are conducted with populations of patients that are more similar to those who receive treatment in regular medical care. This method could help overcome limitations of observational studies, such as the limitations of relying on volunteers and the lack of accessibility and coding flexibility in national registries.

Pragmatic trials have other advantages, such as the ability to use existing data sources, and a greater probability of detecting meaningful differences from traditional trials. However, these trials could be prone to limitations that compromise their reliability and generalizability. Participation rates in some trials may be lower than expected due to the healthy-volunteering effect, financial incentives, or competition from other research studies. Many pragmatic trials are also limited by the need to enroll participants in a timely manner. Additionally, some pragmatic trials lack controls to ensure that the observed differences aren't due to biases in the conduct of trials.

The authors of the Pragmatic Free Trial Meta identified 48 RCTs that self-described themselves as pragmatist and published from 2022. The PRECIS-2 tool was used to evaluate the pragmatism of these trials. It includes areas such as eligibility criteria as well as recruitment flexibility as well as adherence to interventions and follow-up. They found 14 trials scored highly pragmatic or pragmatic (i.e. scoring 5 or more) in at least one of these domains.

Trials that have high pragmatism scores tend to have more lenient criteria for eligibility than conventional RCTs. They also contain patients from a variety of hospitals. According to the authors, could make pragmatic trials more useful and useful in the daily practice. However, they don't guarantee that a trial is free of bias. The pragmatism is not a fixed characteristic; a pragmatic test that doesn't have all the characteristics of an explanatory study could still yield valuable and valid results.